Arizona Arrhythmia Innovative Research (AAIR) is committed to advancing
medical knowledge and excellence in patient care.

Arizona Arrhythmia Innovative Research is the research and education affiliate of Arizona Arrhythmia Consultants. In addition to contributing to scientific knowledge, AAIR offers our patients access to progressive treatments and preventative strategies.

Because clinical trials are experimental, the short and long-term effects of the products or procedures being tested are not always beneficial. Because of this AAIR is very selective about the clinical trials in which it agrees to participate.

What is a clinical research trial?

A clinical trial is a research program conducted with patients to evaluate a new medical treatment, drug or device. The purpose of clinical trials is to find new and improved methods of treating different diseases and special conditions.

There are four phases of a clinical trial:

Phase I: a new research treatment is given to a small number of participants. The purpose is to determine the best way to give the new treatment and how much of it can be given safely.

Phase II: clinical trials determine the effect of a research treatment on a particular disease or condition.

Phase III: clinical trials compare the new treatment with the standard treatment

Phase IV: clinical trials apply the new treatment to patient care

Who can participate?

Every clinical trial is designed to look at a specific set of patients. Each study enrolls patients with certain conditions and symptoms. If you fit the guidelines, you may be able to participate. In some instances, you may be asked to undergo certain tests to make sure you are appropriate for the study.

What are the advantages?

During the Phase IV clinical trial, physicians use the best standard treatment available to evaluate the new treatments. During Phase III the new treatments have shown promise to be at least as effective or possibly more so than standard treatments.

If you participate:
You may receive a new treatment before it is widely available to the public providing valuable information to continue developing these new procedures and treatment methods.

Could there be side effects?

Yes. Side effects will depend on the type of treatment and the patient's condition. All of the risks and side effects of the treatment being researched are not known at the beginning of the clinical trial. Since this is the case, there may be unknown side effects as well as benefits.

It is important to note that most treatments, as well as the condition itself, have potential side effects. In clinical trials, most side effects from the treatment are temporary and go away once the treatment is stopped. Patients will be informed of any known possible side effects that occur while they are participating in a trial.

What is informed consent?

Informed consent means that as a patient, you are given all the available information so that you understand what is involved in a specific clinical trial. Your doctor or nurse should explain the treatment to you, including benefits and risks.

You will be given an informed consent form. Read it and consider it carefully. Ask the physician or nurse to explain any parts of the form that are not understandable to you. You are free to decide whether or not to take part in the trial. If you decide to take part in the study, you must sign the consent form. If you do not want to participate in the trial, you can say "No." If you choose not to participate in the trial, your current standard care will not be affected in any way.

Questions to ask your doctor

If you are thinking about taking part in a clinical trial, find out as much as possible about the study before you decide to participate. Here are some questions you may want to ask your doctor or nurse:

What is the purpose of the study?

What has previous research of this drug or treatment shown?

What kinds of tests and treatments does the trial involve?

What is likely to happen in my case with, or without, this new research treatment? (How does this
research study compare with standard treatment options?)

What phase is this clinical trial?

How could the clinical trial affect my daily life?

What side effects can I expect from the clinical trial? (Remember, side effects may occur
from standard treatments and from the disease itself.)

How long will the study last?

Will the clinical trial require extra time on my part?

Will my records remain confidential?

Will the study cost me anything?

Will I have to be hospitalized?

If I agree to withdraw from the clinical trial, will my care be affected?